A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease.

Key facts

Study ID

NCT03110822

Run by

Oncotherapeutics

People needed

134

Starts

2017-02-01

Expected to finish

2027-02-01

Last updated by the study team

2023-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
• Has a diagnosis of MM based on standard criteria as follows:
• Major criteria:
• Plasmacytomas on tissue biopsy.
• Bone marrow plasmacytosis (greater than 30% plasma cells).
• Monoclonal immunoglobulin spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL or kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis.
• Minor criteria:
• bone marrow plasmacytosis (10% to 30% plasma cells)
• monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• lytic bone lesions
• normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL
• Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
• any 2 of the major criteria
• major criterion 1 plus minor criterion 2, 3, or 4
• major criterion 3 plus minor criterion 1 or 3
• minor criteria 1, 2, and 3, or 1, 2, and 4
• Currently has MM with measurable disease, defined as:
• a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
• urine monoclonal protein levels of at least 200mg/24 hours
• for patients without measurable serum and urine M-protein levels, an involved SFLC > 100 mg/L or abnormal SFLC ratio
• for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 1500 mg/L or meet other measurable disease eligibility criteria
• Currently has progressive MM
• MM patients that are relapsed or have refractory disease from at least 2 regimens or lines of therapy including an IMID and a proteasome inhibitor, are eligible for enrollment provided they fulfill the other eligibility criteria:
• Patients are considered relapsed, when they progress greater than 8 weeks from their last dose of treatment.
• Patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose.

You may not qualify if…

• Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 × 10E9/L circulating plasma cells by standard differential)
• Primary amyloidosis
• Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
• Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
• Myocardial infarction within 6 months prior to enrollment
• New York Heart Association (NYHA) Class II or greater heart failure or uncontrolled angina
• Clinically significant pericardial disease
• Severe uncontrolled ventricular arrhythmias
• Echocardiogram or MUGA evidence of LVEF below institutional normal within 28 days prior to enrollment
• Electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Severe hypercalcemia, i.e., serum calcium ≥ 12 mg/dL (3.0 mmol/L) corrected for albumin
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (vertebroplasty or kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a subject with a recent history of kyphoplasty with the medical monitor).
• Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide)
• Received the following prior therapy:
• Chemotherapy within 3 weeks of study drugs
• Corticosteroids (>20 mg/daily prednisone or equivalent) within 3 weeks of study drugs to ensure that steroid dose intensity at the beginning of the treatment is not altered by administration of steroids prior to the study. Consumption of steroids within 3 weeks of the treatment may interfere with efficacy and side effects due to differences of steroid intensity.
• Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
• Lenalidomide within 7 days before study drugs
• Lenalidomide within 21 days before study drugs (Part 4 only)
• Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
• Use of any other experimental drug or therapy within 28 days of study drugs

Where it is running

• James R. Berenson M.D. Inc. — West Hollywood, California, United States (enrolling)
• Cancer Specialists, LLC — Jacksonville, Florida, United States (enrolling)
• California Cancer Associates for Research & Excellence (cCARE) — Encinitas, California, United States (enrolling)
• Wellness Oncology and Hematology — West Hills, California, United States (enrolling)
• Global Oncology, Inc. — Alhambra, California, United States (enrolling)
• Sansum Clinic- Ridley-Tree Cancer Center — Santa Barbara, California, United States
• Millennium Oncology Research Clinic — Pembroke Pines, Florida, United States
• Regional Cancer Care Associates (RCCA) MD, LLC — Bethesda, Maryland, United States
• Northwest Medical Specialists, PPLC — Tacoma, Washington, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Compassionate Care Research Group, Inc. — Fountain Valley, California, United States
• Robert A. Moss, M.D., F.A.C.P., Inc. — Fountain Valley, California, United States
• Pacific Cancer Care — Monterey, California, United States

Full record on ClinicalTrials.gov

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